Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05561114 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

Study acronym: PATENT-E
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jul 2025 to Oct 2026
    • Study completion date: Dec 2029 to Apr 2031
    v10
  2. Study sites: 35 to 34v9
  3. Study sites: 30 to 35v8
  4. Study sites: 26 to 30v7
  5. Study sites: 20 to 26v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jul 1, 2024 to Jul 2025
    • Study completion date: Dec 1, 2029 to Dec 2029
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 13 to 5
    v5
  2. Study sites: 3 to 20v4
  3. Start date changed from estimate of Sep 1, 2023 to Dec 1, 2023v3 Show 5 more changesShow less
    • Study sites: 2 to 3
    • Primary completion date: Aug 1, 2024 to Jul 1, 2024
    • Study completion date: Feb 1, 2029 to Dec 1, 2029
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 3 to 13
  4. Start date: Oct 1, 2022 to Sep 1, 2023
    • Study sites: 1 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Trial Details
NCT Number NCT05561114
Lead Sponsor GIE Medical
Conditions
(from sponsor)		 Esophageal Stricture
Related terms Esophageal Stenosis
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov